List of Dietary Fibres Reviewed and Accepted by Health Canada's Food Directorate

List of Dietary Fibres Reviewed and Accepted by Health Canada’s Food Directorate

List of Dietary Fibres Reviewed and Accepted
    by Health Canada’s Food Directorate

                                                                       Revised December 2013

 Bureau of Nutritional Sciences, Food Directorate, Health Products and Food Branch   1

List of Dietary Fibres Reviewed and Accepted by Health Canada’s Food Directorate

Regulatory Requirements

The Food and Drug Regulations do not require pre-market assessment for dietary fibre.
However, a novel fibre source or a novel fibre-containing product must be safe for human
consumption (Section 4 of the Food and Drugs Act), and a product represented as containing
dietary fibre must have the physiological effect expected of dietary fibre (Subsection 5(1) of the
Food and Drugs Act). Fibre declaration and claims are subject to post-market oversight and
manufacturers or importers are expected to have evidence (in-house) substantiating the safety
and the physiological function of novel fibre sources in accordance with the 2012 Health
Canada’s Policy for Labelling and Advertising of Dietary Fibre-Containing Food Products.

When the food industry voluntarily submits for review a novel fibre information package, a pre-
market assessment is initiated by the Food Directorate’s Bureau of Nutritional Sciences. This
assessment is conducted on a case-by-case basis, and will result in the issuance of a letter of
opinion expressing no objection to those novel fibres that are considered acceptable for use in
foods available for sale in the Canadian marketplace.

The purpose of this document is to provide the updated list of dietary fibres assessed and found
acceptable by the Food Directorate, Health Canada. It must be noted that other accepted fibres
not listed in this document may be available on the Canadian marketplace. The onus is on the
legal agent to comply with Sections 4 and 5 of the Food and Drugs Act.

Dietary Fibre Definition

The Policy for Labelling and Advertising of Dietary Fibre-Containing Food Products defines
dietary fibre as follows:

“Dietary fibre consists of:

       1) carbohydrates with a degree of polymerization of 3 or more that naturally occur in
       foods of plant origin and that are not digested and absorbed by the small intestine; and

       2) accepted novel fibres.

Novel fibres are ingredients manufactured to be sources of dietary fibre and consist of
carbohydrates with a degree of polymerization of 3 or more that are not digested and absorbed
by the small intestine. They are synthetically produced or are obtained from natural sources
which have no history of safe use as dietary fibre or which have been processed so as to modify
the properties of the fibre contained therein. Accepted novel fibres have at least one
physiological effect demonstrated by generally accepted scientific evidence.”

The four recognized physiological effects of dietary fibres are:
       improving laxation or regularity by increasing stool bulk;

Bureau of Nutritional Sciences, Food Directorate, Health Products and Food Branch            2

List of Dietary Fibres Reviewed and Accepted by Health Canada’s Food Directorate

            reducing blood total and/or low-density lipoprotein cholesterol levels;
            reducing post-prandial blood glucose and/or insulin levels;
            providing energy-yielding metabolites through colonic fermentation.

 Accepted Dietary Fibres

 Accepted dietary fibres are permitted to be used in all unstandardized foods with the exception of
 infant formula unless otherwise specified. Unstandardized foods are foods for which the Food
 and Drug Regulations do not provide specific compositional standards. The addition of dietary
 fibres is not permitted in standardized foods unless a provision for their addition is made in the
 Food and Drug Regulations. The table below provides the list of dietary fibres assessed and
 accepted by Health Canada.

 Table 1. List of dietary fibres reviewed and accepted by Health Canada’s Food Directorate

      Dietary Fibre                                              Description

Acacia Gum (Gum Arabic)        Dried exudate from stems and branches of Acacia senegal and Acacia seyal
                               species, processed by water dissolution, purification, concentration and drying

Barley bran                    Obtained from dehulled or hull-less barley grain using standard dry milling
                               techniques, which may include steaming or tempering

Beta-glucan concentrate        Chemically extracted from oat or barley grain, followed or not by partial
from oat or barley             hydrolysis

Corn bran                      Corn grain pericarp separated by conventional dry- or wet- corn milling process-
                               Maximum use level in high fibre cereal is 46.7%

Corn syrup (fibre)             PromitorTM Soluble Corn Fibre 70 (Tate & Lyle)

Fructooligosaccharides or      Mixture of fructose oligomers obtained by partial hydrolysis or by physical
oligofructose                  separation of traditional inulin sources, or enzymatically produced from sucrose

Galactooligosaccharides        Mixture of galactose oligomers enzymatically produced from lactose derived
                               from whey

High amylose corn starch       Obtained from milling process of high amylose corn grain, followed or not by
                               hydrothermal treatment. Amylose content in high amylose corn varies from 50 to
                               90%

Inulin from chicory root,      Standard inulin and long chain inulin obtained by hot water extraction and/or by
Jerusalem artichoke tuber      conventional separation processes
or Blue agave head

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List of Dietary Fibres Reviewed and Accepted by Health Canada’s Food Directorate

Isomaltooligosaccharides       Mixture of glucose oligomers enzymatically produced from starch and modified
                               through transglycosylation reaction

Maltodextrin (fibre) or        Partial hydrolysis of edible starch by heat/acid/enzymatic treatment followed by
resistant maltodextrin from    sugar removal. The product consists of polymers of glucose containing α(1-4)
corn, potato, tapioca, rice,   and α(1-6) glucosidic bonds, as well as α/ß(1-2) and α/ß(1-3) linkages
etc.

Modified wheat starch          Fibersym® RW and FiberRite® RW (MGP Ingredients, Inc.)

Oat bran                       Derived from dehulled oat kernels (oat groat) and providing at least 13% total
                               dietary fibre, of which at least 30 percent must be soluble fibre

Oat hull fibre                 Outer layer of oat grain processed by hydro-thermal high pressure treatment, by
                               alkaline hydrogen peroxide treatment, or by other conventional treatments

Partially hydrolyzed guar      Sunfiber® (Taiyo International, Inc.)
gum

Pea hull fibre                 Outer seed coat of field peas obtained by mechanical separation, by extraction of
                               pea soluble material, or by other conventional processes

Polydextrose                   Obtained by condensation of a melt consisting of approximately 90% glucose
                               and 10% sorbitol in the presence of catalytic amounts of citric acid or phosphoric
                               acid

Polysaccharide complex         PGX®/PolyGlycopleX® (InovoBiologic)
(glucomannan, xanthan
gum, sodium alginate)

Psyllium seed husk             Dried seed coat of Plantago ovata or Plantago arenaria separated from the seed
                               through a mechanical process

                               Purity: ≥95%; Total fibre: ≥80%; Protein: ≤3%; Light extraneous matter: ≤4.5%;
                               Heavy extraneous matter: ≤0.5%; Combined extraneous matter: ≤4.9%.

                               Recommended warning statements on the label of psyllium-containing products
                               - "This product may cause allergic reaction in people sensitive to inhaled or
                               ingested psyllium" - For products containing dry or incompletely hydrated
                               psyllium husk, in Directions for Use section, indicate necessity to consume the
                               product with enough fluid in order to avoid throat obstruction

Sieved barley meal             Beta-glucan concentrated via air classification of dry-milled barley grain

Soy cotyledon                  Derived from processing dehulled and defatted soybean flakes in mild alkaline
                               conditions

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List of Dietary Fibres Reviewed and Accepted by Health Canada’s Food Directorate

Sugar beet fibre               Obtained from sugar beet pulp by pressing, steam drying and milling -
                               Maximum use level in foods is 7%

Wheat flakes, starch-          Obtained from the amylolytic digestion of milled wheat kernel used for ethanol
reduced                        production

Wheat bran                     Outer layer of wheat grain obtained during wheat flour milling process

Whole or edible parts (for     Processed through conventional procedures
example, flour, pulp and
peel) of traditional fruits,
vegetables, cereals,
legumes, nuts, seeds, etc.

  Manufacturers and distributors are legally responsible for ensuring that their product complies
  with all relevant food legislation and regulations and for the accuracy of all information on food
  product labels and in advertisements.

  Additional Information on Dietary Fibre Policy

          Policy for Labelling and Advertising of Dietary Fibre-Containing Food Products
          Proposed Policy: Definition and Energy Value for Dietary Fibre
          Guideline Concerning the Safety and Physiological Effects of Novel Fibre Sources and
          Food Products Containing Them

  Contact Us

  Manufacturers who are considering the use of novel fibre sources and require further guidance
  on the fibre policy may contact the Bureau of Nutritional Sciences in writing, by mail or
  electronically.

  Bureau of Nutritional Sciences
  Food Directorate
  251, Sir Frederick Banting Driveway
  Tunney’s Pasture, A.L. 2203E
  Ottawa, Ontario
  K1A 0K9

  Email address: fibre@hc-sc.gc.ca

  Bureau of Nutritional Sciences, Food Directorate, Health Products and Food Branch                     5